Design Verification of Combination Products

3/22/2022 12:25 - 12:55

  • Characterization testing for generic combination products – what is expected?
  • Robust verification strategy & regulatory agency expectations
  • Importance of Engineering qualifications – Impact of failures during final DV
  • Utilizing verification data from CRO/CMO into OEM data
  • Attribute vs Variable (why variable testing is preferred) – Test case
  • Possible ways to balance between design changes, verification, and usability at the same time – Test case.

Ajay Bapurao Chintawar, Drug Delivery Systems Development Lead , Pharmathen